FDA.reportPublic FDA data

Water Purification System for Hemodialysis

Primary DI
00860006352127
Brand
Water Purification System for Hemodialysis
Company
Nelson Environmental Technologies Inc
Model
Complete System
Device description
Nelson Water System's Water Purification System for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment. It removes organic, inorganic, and microbial contaminants from the water.
Published
2023-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993877000NELSON WATER SYSTEMS FOR HEMODIALYSISNelson Environmental Technologies, Inc.2000-05-25FIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006352127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006352127008600063521278600063521270860006352127

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
835316464
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006352165Chlorine Sentinel IINSS-CS-II-0012025-04-16
00860006352103Basic Chlorine SentinelNSS-BCS-0012022-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013284107Carbon TankBTI FiltrationFIP2026-10-27
00860013284114Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284121Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284138Mixed Bed DI tankBTI FiltrationFIP2026-10-27
00860013284145Carbon TankBTI FiltrationFIP2026-10-27
00860013284152Carbon TankBTI FiltrationFIP2026-10-27
00860013284169Carbon TankBTI FiltrationFIP2026-10-27
00860013284176Carbon TankBTI FiltrationFIP2026-10-27
00817927020345AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020352AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020369AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020376AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020383AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020390AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020406AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020413AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
04039361261313DIASAFE®plusUSFresenius Medical Care AGFIP2026-05-01
00850001011266Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011341Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011358Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00860008016942Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
PB0002MEDI-PORT PBII R.O. 220VBETTER WATER, LLCFIP2024-11-13
PB0003MEDI-PORT PBII R.O. 120VBETTER WATER, LLCFIP2024-11-13